September 19 2023, 09:00 BST

Aparito, a digital health technology company, and Garmin, a leading global provider of smartwatches, fitness trackers and digital health solutions, have ratified their collaboration to integrate Garmin smartwatches into Aparito’s Atom5™ clinical trial platform. The collaboration aims to capture real-world data and develop new digital endpoints and will be managed by the Garmin Health enterprise business solutions team.

The integration of Garmin smartwatches with the Aparito Atom5™ platform allows patients to perform clinical outcome assessments (COAs) at home such as the six-minute walk test (6MWT), and passively capture data such as sleep, heart rate and activity levels, making clinical trials more accessible to patients and providing richer data to clinicians utilizing an integration of the Garmin Health SDK.

Dr. Elin Haf Davies, Aparito CEO, said, “We collaborated with Garmin due to the integrity of their Health SDK and their collaborative culture. Working together to connect Garmin devices directly to our applications ensures we get access to raw data rather than relying on black box metrics and algorithms.”

“A strong network of technology collaborators is essential for us – especially in the research and clinical trials space. Together with Aparito, we are glad to provide a solution to researchers and clinicians for unique access to physiological data that is both digital and scalable,” said Dr. Leon Brudy, Garmin Health Business Development Manager. 

Ongoing collaborations between Aparito and Garmin are in place across many projects, including early-phase clinical trials, registry studies and digital biomarker development.

Join Aparito and Garmin Health at SCOPE Europe in Barcelona this October 17 and 18 where they will share their progress in digitising the 6-Minute Walk Test in conjunction with Dr. Joe Newman from Royal Papworth Hospital and the PHA UK patient group.

For more information on our collaborative projects, please visit this Garmin blog and this Aparito blog.

About Aparito

Aparito’s mission is to digitise clinical trials and accelerate drug development for patients with life-limiting diseases by supporting patient-centric clinical trials with innovative treatments.

Clinical trials can be conducted within patients’ homes by leveraging our Atom5™ platform incorporating disease-specific smartphone apps, video assessments and wearable technology to digitise clinical trials using novel eCOA and generate continuous real-world data. 

Aparito’s patient-generated data platform is disease-agnostic and scalable, ready for rapid deployment in global rare disease studies. 

Discover more about how we digitise clinical trials on LinkedIn, Twitter and at aparito.com. 

About Garmin Health

​​​​​​​Garmin Health provides custom enterprise business solutions that leverage Garmin’s extensive wearable portfolio and high-quality sensor data for applications in the corporate wellness, population health, and patient monitoring markets. The Garmin Health API allows third parties to ask customers to share their data in accordance with their specific privacy policies. 

As part of a global company that designs, manufactures and ships products worldwide, Garmin Health supports its customers’ commerce and logistics needs, allowing enterprises to scale with a single, trusted provider. For more information, email Garmin’s press team, connect on LinkedIn, or visit online at garmin.com/health.​​​​

An update from Aparito CEO, Dr Elin Haf Davies.

Over the last three months, I have been privileged to co-author three papers.

Each one is different, but each one with the same central theme, the patient, and each one with the word patient in the title: 

Tanya Collin-Histed, Madeline Stoodley, Kathleen Beusterien, Deborah Elstein, Dena H. Jaffe, Shoshana Revel-Vilk, Elin Haf Davies on behalf of the International Gaucher Alliance(2023) A global neuronopathic Gaucher disease registry (GARDIAN): a patient-led initiative (IGA) Orphanet Journal of Rare Diseases volume 18, Article number: 195

Aiyegbusi, O.L., McMullan, C., Hughes, S.E., Davies, E.H., et al. Considerations for patient and public involvement and engagement in health research. TLC Study Group (2023) Nature Medicine 

Wicks, P., Wahlstrom-Edwards, L., Fillingham, S., Downing, A., Davies E.H (2003) So You Want to Build Your Disease’s First Online Patient Registry: An Educational Guide for Patient Organizations Based on US and European Experience The Patient – Patient-Centered Outcomes Research volume 16, pages 183–199

My co-authors for the three papers are different collaborators, but all are focused on the importance of incorporating the patient’s voice into research and enabling the patient’s voice to be captured in a methodologically robust way.

Turning their voices into data. 

Over the two-plus decades that I’ve worked in clinical research, I’ve been notably aware that ‘Not everything that can be counted counts and not everything that counts can be counted‘ (as attributed to Albert Einstein).

From the first clinical trial I supported I realised that the endpoints used in clinical trials very rarely reflect what’s important to patients and families in their day to day.

That first clinical trial remains the driver for much of my work in neuronopathic Gaucher disease, and despite the challenges along the way, our paper in Orphanet describing the “A global neuronopathic Gaucher disease registry (GARDIAN)” and our efforts to develop disease-specific Patient Reported Outcomes and data-driven insight to guide better clinical trial designs in the future. 

Ultimately, insight and new knowledge are generated through data, and data is required to convince the regulators and reimbursement agencies that new medicines have the efficacy and effectiveness to be approved and reimbursed. 

While it’s the personal story that wins the hearts and minds via a headline story, the personal story is not what gets medicines approved: “Bring me data, not tears” is the well-known line reported to be told by an FDA to a mother of a child living with a rare life-threatening illness while reviewing a dossier for approval. 

Put another way, “In God we trust, all others must bring data”. 

Much has changed in the role of patients in the design and approval of medicines over the last two decades. Our recent blog with Neil Bertelsen reflects on the birth of modern patient advocacy back in the 1980s.  “That led to the FDA forming what is now their patient engagement policy, and it started with its HIV-specific patient council that advised the FDA and was later expanded to include more diseases”.

As Aparito rapidly approaches its ninth birthday it’s time to pause and review the data to reflect on where we’re at today. Are we still driving towards the original mission? Personally, there is pride that I have managed to maintain the patient central to all that I aspired to do with Aparito. 

Being awarded the Made WITH Patient Raising Star for my work in patient engagement was also an important external reflection of our ongoing achievements via the Patient Group Accelerator, which brings me immense satisfaction

Is what is being measured truly what matters?

But there seems to be a dichotomy between the achievements that can be measured in numbers and the aspects that bring me the most pride. 

How does one quantify the achievements over the last nine years? Do we focus on

• the number of patients that have engaged with our Atom5™ platform?
• the number of features that Atom5™ now has?
• the number of studies that we’ve implemented?
• the number of countries that we’re in?
• the number of scientific publications and their respective impact factors?
• the number of staff that we employ?
• the amount of investment we’ve raised?
• the amount of revenue growth that we can show year-on-year? 

It’s easy to be pulled away by other priorities; product, processes, pricing – all inevitable demands to be considered while working towards the ultimate goal of patient value.

But working on a product without considering the patient, focusing on the process without involving the patient, and negotiating a price without evaluating the patient value is to be distracted from the main purpose. 

What a decade it’s been to grow a global med-tech company: a pandemic, war in Europe, raging fires from the impact of climate change, and a high number of refugees losing their lives as they attempt to cross waters for a safer life. 

Some notable digital health companies that closed significant investments and sky-high valuations have crumbled, and the macro-economic continues to be unpredictable.  

As the pressures of building a company take their toll, I now have greater confidence to walk away from those who don’t buy into the mission, and to only work with people who have the same vision during the highs and the lows! 

People that stick with you through thick and thin, and are good, fun, kind people to work with.  

As we look towards our 10th year, I remain fully committed to the goal that I set for myself when I founded Aparito, to support patient-centric clinical trials by measuring what matters to patients. 

Sign up for our newsletter to receive our latest papers, posters and platform updates direct to your inbox

On World Duchenne Awareness Day, Duchenne UK and Aparito announce a new study to help validate a new approach, the DMDhome digital platform, to testing drugs in clinical trials.

The DMDhome platform is the result of a successful collaboration between Duchenne UK and Aparito which uses video capture and computer vision analysis to measure limb function in Duchenne muscular dystrophy (DMD). The study will aim to validate this new approach for use in clinical trials and potentially in the approval of new medicines for DMD.

Run by health technology company Aparito using the Atom5™ clinical trial platform and co-funded by Duchenne UK and Joining Jack, the study will focus on assessing upper and lower limb function in DMD, particularly in the transfer phase which is the transition from the ambulant (walking) to non-ambulant (non-walking) stage.

The study will be fully decentralised which means that those taking part can do so in their home as opposed to having to travel to a clinical site.

DMDhome – a new electronic clinical outcome assessment

DMDhome was developed following Duchenne UK being chosen to join Aparito’s Patient Group Accelerator Programme in 2020 with the intention of devising a patient-centred electronic clinical outcome assessment (eCOA), which was able to capture changes in functional ability and their impact on meaningful daily-life activities.

The aim of the video capture and computer vision assessment was to identify disease features specific to DMD and the best way to capture and measure them.

This initial work found that the DMDhome platform is a viable way to give and record instructions for motor tasks to participants via video and to collect the results that participants report, including quality of life data capture using the DMD Quality of Life Measure (DMD QoL).

The proof of concept data was published in 2022.

Aims of DMD validation study

A rigorous clinical validation approach to test DMDhome will be rolled out in a natural history study (a study that tracks the course of a disease over time) to assess the clinical significance and reliability of new electronic clinical outcome assessments (eCOAs) compared to the traditional assessments currently used. As in the previous study, quality of life data from participants and their families will also be captured, using the DMD QoL.

It is expected that the study will lead to a comprehensive data set to support the use of DMDhome video assessments as digital endpoints in DMD clinical trials to assess both disease progression and potential drug benefit, and ultimately, in time, support its qualification as a eCOAs by medicines regulators.

Importance of study

Emphasising the importance of this work and its significance for people with DMD and their families, Alessandra Gaeta, Director of Research at Duchenne UK, said:

“The DMD ‘transfer stage’, which sees the transition from the ambulant to the non-ambulant stage of the disease, involves a huge change in quality of life for people living with the condition and their carers.  Despite this, there is no validated assessment in the clinic yet that captures this stage accurately and consistently.

“That’s why, once validated, DMDhome has the potential to become an important tool in the toolkit to assess and measure changes in motor function at this stage, supporting the understanding of impact of new treatments on the disease and on quality of life.”

The study has been designed by Aparito in collaboration with the University of Oxford. Laurent Servais, Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre, who is the Principal Investigator, outlines its aims:

It is very exciting to take part in new developments in the field of digital outcomes. We need more granularity when we assess our patients – in order to build shorter and more efficient clinical trials. I am very happy to see the focus on a population that we neglect too often in outcome development and thus in clinical trial – the population of patients in transition

Laurent Servais, Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre

This study represents the consolidation of the partnership between Aparito and Duchenne UK and a great achievement for Aparito’s Patient Group Accelerator Programme, which supports the co-creation process of new eCOAs and digital endpoints with patients. Validating DMDhome will be a major step towards the acceptance and use of patient-centric digital outcome measures in rare disease medicine development.

Dr Elisa Ferrer Mallol, Patient Engagement Manager at Aparito

Recruitment for DMD Home validation study

The study will open recruitment of eligible participants over the next few months. This will be announced via the DMD Hub.

Facts and figures about DMD

About Aparito
Aparito’s mission is to digitize clinical trials and accelerate drug development for patients with life-limiting diseases by supporting patient-centric clinical trials with innovative treatments. Clinical trials can be conducted within patients’ homes by leveraging our Atom5™ platform incorporating disease-specific smartphone apps, video assessments and wearable technology to deliver digital clinical trials using novel eCOA to generate continuous real-world data. Aparito’s patient-generated data platform is disease-agnostic and scalable, ready for rapid deployment in global rare disease studies.

About Duchenne UK

Duchenne UK is a charity that was set up in 2012 by Emily Reuben and Alex Johnson following both of their sons being diagnosed with DMD. They set up Duchenne UK to tackle some of the big challenges in drug development in their search to accelerate the development of treatments. In 11 years, Duchenne UK has raised more than £20 million and used this money to:   

• Fund clinical trials of medicines that are now showing promise for DMD 
• Set up DMD Care UK, a national care programme for patients with DMD to stop patients with DMD from dying too young because they were not getting the right care. The programme establishes best practice across all the disciplines involved in DMD care and works to ensure all medical professionals and parents know precisely what treatment children and adults with DMD need. 
• Create a DMD medical research hub with hospital sites across the country, which has led to more trials for DMD treatments than ever before.  
• Develop innovative technologies, the SMART Suit and Dream Chair, to support the independence of people with DMD.  

You can find out more about the work of Duchenne UK at duchenneuk.org

August 09 2023, 09:00 CEST

Since announcing the launch of the Digital Tools for Rare Disease project (DT4RD), a product of the Rare Disease Research call placed by the European Joint Programme on Rare Diseases in partnership with Fondation Maladies Rares sponsored by Chiesi and CSL Behring, extensive progress has been made!

Non-invasive tools for measuring rare disease patient mobility in daily living and distinguishing between voluntary and involuntary movements were put in place using state-of-the-art wearable sensors integrated with Aparito’s Atom5^TM clinical trial platform to capture physiological and psychosocial parameters. 

The main objective of this project has been focused on developing and validating a way to acquire, transfer, store and process heterogeneous data related to movement measured at home and anchored to assessments performed at the hospital, as Clinical Outcome Measures (eCOA).

This European study involves great collaboration with renowned clinical experts located at the Institute of Myology (Paris, France), and at the John Walton Muscular Dystrophy Research Centre (Newcastle, UK).

After the French Ethics Committee’s approval, the Institute of Myology is proud to announce their First Patient recruited into the study on the 3rd of July 2023!

The enrolment went very well although a bit longer than expected to explain in detail the protocol and train the patient with the digitised tools including the Atom5^TM platform with video tasks and ePRO to complete, the Garmin Vivosmart5 wearable device and the Yumen Bionics wearable sensors.

Dr Jean-Yves Hogrel, Director of the Laboratory of Neuromuscular Physiology and Evaluation at the Institute of Myology

The patient expressed her motivation for taking part in this study related to the mobility of patients affected by rare neuromuscular diseases. Afterwards, she declared: “I felt comfortable, not too tired and confident to carry the tasks at home independently”.

The Institute of Myology Team added: “We are in the process of recruiting very soon our next patient on the 1st of September 2023 and keep on enrolling a total of 20 patients in the next few months.”

This is a great milestone which reflects a wonderful collaboration to date. We are always grateful when patients enrol on our studies and appreciate their time and dedication to develop innovation that will hopefully be used in patient-centric clinical trials to convey what’s important to patients.

Dr Elin Haf Davies, CEO of Aparito

By digitising critical procedures within the clinical trial process, Aparito leads this project with European Clinical partners as well as renowned technology and industry partners to provide real-time visibility of data collection and integrity, reducing patient and site burden, enhancing the patient experience, and improving patient retention.

This EJP-DT4RD study is supported by the Atom5^TM platform’s innovative technology in the patient’s homes using disease-specific smartphone apps, video assessments, and wearable technology to deliver meaningful data through eCOAs and the development of digital biomarkers.

About Aparito
Aparito’s mission is to digitize clinical trials and accelerate drug development for patients with life-limiting diseases by supporting patient-centric clinical trials with innovative treatments. Clinical trials can be conducted within patients’ homes by leveraging our Atom5™ platform incorporating disease-specific smartphone apps, video assessments and wearable technology to deliver digital clinical trials using novel eCOA to generate continuous real-world data. Aparito’s patient-generated data platform is disease-agnostic and scalable, ready for rapid deployment in global rare disease studies.

About the Institute of Myology

The Institute of Myology, located in Paris, coordinates medical management, research, and education related to muscle diseases and injuries. It is an international reference centre that participates in numerous trials and clinical studies, with a focus on neuromuscular diseases, high-performance sports, and ageing. The Institute of Myology Association facilitates the coordination of site activities in partnership with five public guardianship organisations, and the institute includes a complete Center of Research in Myology and several scientific poles as well as clinical activities.

Find them on https://www.institut-myologie.org/en/

About the EJP-DT4RD project

A unique project involving Academics (Institute of Myology, John Walton Muscular Dystrophy Research Centre), SMEs (Aparito, Yumen Bionics), large pharmaceutical companies (Chiesi, CSL Behring), and a patient organisation (MSUK) working towards the same objective for and with patient involvement. It widens the horizon of tremendous possibilities for the future of research in rare diseases and warrants hope for future clinical trials using Real World data.

Find out more at https://www.ejprarediseases.org/rare-diseases-research-rdr-challenge-1-digital-tools-for-rare-disease-dt4rd/

July 31 2023, 09:00 EST

Aparito and TruLab, two companies focused on improving rare disease studies, have formed a partnership to improve the efficiency and experience of clinical trials.

TruLab’s technology has gained traction in the rare disease space due to the difficulty of obtaining samples, especially from children, and the criticality of the sample for the patient’s eligibility in the study. Both Aparito’s and TruLab’s mobile platforms are designed to maintain data integrity and minimize the potential for data loss.

By leveraging Aparito’s Atom5™ platform, clinical trials can be supported in the patients’ homes using disease-specific smartphone apps, video assessments, and wearable technology to deliver meaningful data through eCOAs and digital biomarkers.

Collectively the companies intend to reduce the burden on parents and caregivers seeking treatment for their children. The application of innovative technologies in this setting ensures that patient samples and data points are collected according to study procedures and are not lost, ultimately increasing the chances of success in the clinical trial.

By digitizing critical procedures within the clinical trial process, TruLab and Aparito can provide real-time visibility to data collection and integrity, reduce patient and site burden, enhance the patient experience, and improve patient retention.

“We are excited to partner with TruLab to improve the collection and management of samples in rare disease studies,” said Dr Elin Haf Davies, CEO of Aparito. “Our Atom5™ platform will help ensure that the patient-generated data collected is of the highest quality, ultimately leading to a better clinical trial experience for people living with rare diseases.”

“We are delighted to partner with Aparito to provide a seamless solution for rare disease studies,” said Jim Wahl, Vice President of Client Services at TruLab. “Our combined technologies will enable us to provide high-quality data to support the development of treatments for rare diseases.”

The partnership between Aparito and TruLab is a significant step forward in rare disease research. With the two companies working together, researchers will have access to platforms that provide real-time visibility and improve the quality of data collected and ultimately lead to better treatments for patients with rare diseases.

About Aparito
Aparito’s mission is to digitize clinical trials and accelerate drug development for patients with life-limiting diseases by supporting patient-centric clinical trials with innovative treatments.

Clinical trials can be conducted within patients’ homes by leveraging our Atom5™ platform incorporating disease-specific smartphone apps, video assessments and wearable technology to digitise clinical trials using novel eCOA and generate continuous real-world data. 

Aparito’s patient-generated data platform is disease-agnostic and scalable, ready for rapid deployment in global rare disease studies.

Discover more at aparito.com.

About TruLab
TruLab, Inc. is a sample management software company that provides advanced point-of-collection workflow solutions for the clinical research industry.

TruLab’s technology is designed to help clinicians, labs and pharmaceutical sponsors manage their clinical samples more effectively, while ensuring consistent compliance with study protocols and achieving target levels of data quantity and quality.

TruLab also enables real-time visibility of clinical procedures and sample status for pharmaceutical and lab customers, especially in a decentralized trial environment.

Learn more at trulab.com.